Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma

Shanghai Jiao Tong University

Status and phase: Completed; Phase 2

Conditions: Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma

Treatments: Drug: Axitinib; Drug: Toripalimab

Study type: Interventional

Funder types: Other

Identifiers

NCT04118855

Neo-RCC

Details and patient eligibility

About

This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). This is a single-institution, single-arm phase 2 clinical trial.

Full description

This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). This is a single-institution, single-arm phase 2 clinical trial. Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk. Patients then will receive partial or radical nephrectomy after neoadjuvant therapy.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-metastatic biopsy-proven clear cell renal cell carcinoma (T2-T3N0-1M0)
• Schedule to undergo either partial or radical nephrectomy as part of treatment plan
• ECOG performance status of 0 or 1
• Adequate organ and marrow function defined by study-specified laboratory tests
• Agree to comply with scheduled visits, treatment plans, lab tests and other study procedures
• Do not have any other cancers in the 5 yr preceding diagnosis of their renal cancer

Exclusion criteria

• Patients who have received other systems for anti-tumor treatment
• Patients who have previously received targeted or immunotherapy
• Need for urgent or emergent nephrectomy to relieve symptoms
• Current use of immunosuppressive agents
• Pregnant or breastfeeding women
• History of autoimmune disease or syndrome

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Neoadjuvant arm

Experimental group

Description:

Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.

Treatment:

Drug: Toripalimab

Drug: Axitinib